Point-of-Care PJI Sensor Device for Synovial Fluid Analysis
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Solution Overview
Problem
Current diagnostic methods for periprosthetic joint infections (PJIs) are not performed at the point-of-care, leading to delays and higher rates of false negatives and false positives, as they require samples to be shipped to specialized laboratories for analysis.
Innovation Solution
A system and method for analyzing criteria for PJI at the patient's point-of-care, using a multimodal sensor device that includes optical sensors and immunoassay strips to detect white blood cell concentration, leukocyte esterase, C-reactive protein, and alpha-defensin in synovial fluid samples, providing immediate diagnostic information.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If samples are shipped to specialized laboratories for analysis, then measurement precision is improved, but loss of time increases and reliability deteriorates due to false negatives and false positives
Solution Approach 1:
The patent replaces the mechanical/physical transport system (shipping samples to laboratories) with an integrated point-of-care testing system that performs all necessary analyses locally. The multimodal sensor device combines optical sensors, immunoassay strips, and processing capabilities in a single portable unit, eliminating the need for sample transportation while maintaining diagnostic accuracy.
Solution Approach 2:
The patent implements a universal diagnostic platform that can perform multiple measurement functions (optical detection, immunoassay, data processing) within a single device. This multi-functional approach allows the system to conduct comprehensive PJI analysis at the point of care without requiring separate specialized laboratory facilities for each test type.
2Measurement precision
If samples are shipped to specialized laboratories for analysis, then measurement precision is improved, but reliability worsens due to higher rates of false negatives and false positives
Solution Approach 1:
The patent replaces the mechanical/physical transport system (shipping samples to laboratories) with an integrated point-of-care testing system that performs all necessary analyses locally. The multimodal sensor device combines optical sensors, immunoassay strips, and data processing capabilities in a single portable unit, eliminating the need for sample transportation while maintaining diagnostic accuracy.
Solution Approach 2:
The patent incorporates real-time feedback mechanisms where the processor continuously monitors sensor readings from optical detectors and immunoassay strips, comparing results against established diagnostic criteria. This feedback loop enables immediate identification of inconsistent or questionable results, allowing for repeat testing or clinician review before final diagnosis is made, thereby reducing false negatives and false positives.
3Loss of time
If a multimodal sensor device with optical sensors and immunoassay strips is used, then loss of time is reduced by providing immediate results, but device complexity increases
Solution Approach 1:
The patent merges multiple previously separate diagnostic components into a single integrated device. Optical sensors, immunoassay strips, data processing units, and user interfaces are combined in one portable system, allowing all necessary PJI analyses to be performed at the point of care. This consolidation reduces diagnostic time by eliminating sample transportation and laboratory waiting periods, while the modular design manages complexity through functional integration.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Enables rapid and accurate diagnosis of PJI at the point-of-care with reduced false negatives and false positives, improving patient outcomes and reducing healthcare costs by providing immediate diagnostic results.
Implementation Method 1
one or more vial optical sensors configured to detect scattered and/or absorbed light intensity by white blood cells in the fluid sample
Implementation Method 2
The marker reagent may be configured to generate at least one marker light intensity from a reaction between the marker reagent and a marker in the fluid sample
Data Source
AI summary
A system, device and method for measuring markers for a periprosthetic joint infection in a sample of synovial fluid. A sensor reader device includes a vial receptacle for receiving a vial containing synovial fluid. A light source illuminates the vial and an optical sensor detects light scattered and/or absorbed by white blood cells in the fluid sample. An electrical signal corresponding to the intensity of the light received at the optical sensor is detected. A white blood cell concentration is determined from the electrical signal value. The sensor reader device also includes one or more immunoassay strip receptacles. Immunoassay strips for other marker are inserted into the receptacles. Immunoassay optical sensors detect light generated by the immunoassay reaction on the immunoassay strip to determine the concentration of the marker. In example implementations, the device includes an immunoassay strip reader for leukocyte esterase and c-reactive protein.